Drugplain

Peroxyl Mouth Sore Mild Mint 15 mg/mL

Hydrogen Peroxide · RINSE · Colgate Oral Pharmaceuticals Inc.

No Recall History
Plain English

Peroxyl Mouth Sore is an over-the-counter hydrogen peroxide rinse used to cleanse and help relieve minor mouth sores and irritation. You rinse your mouth with this mild mint-flavored solution to help manage discomfort from canker sores, gum irritation, and other minor oral wounds.

Key Facts

Brand Name
Peroxyl Mouth Sore Mild Mint
Generic Name
Hydrogen Peroxide
NDC Code (Product)
0126-0083
Manufacturer
Colgate Oral Pharmaceuticals Inc.
Strength
15 mg/mL
Dosage Form
RINSE
Route
BUCCAL
Marketing Status
Application #
M022
Marketing Start
01/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective37 reports
fatigue23 reports
nausea23 reports
vomiting17 reports
headache16 reports
rash16 reports
product use in unapproved indication15 reports
pruritus15 reports
shock haemorrhagic14 reports
dyspnoea13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums

Dosage & Administration

Directions Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children under 12 years of age should be supervised in the use of the product Children under 2 years of age: consult a dentist or physician

Warnings

Warnings Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a doctor if sore mouth symptoms do not improve within 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Peroxyl Mouth Sore Mild Mint used for?

Peroxyl Mouth Sore is an over-the-counter hydrogen peroxide rinse used to cleanse and help relieve minor mouth sores and irritation. You rinse your mouth with this mild mint-flavored solution to help manage discomfort from canker sores, gum irritation, and other minor oral wounds.

Is Peroxyl Mouth Sore Mild Mint a controlled substance?

Peroxyl Mouth Sore Mild Mint is not classified as a controlled substance by the DEA.

What is the generic name for Peroxyl Mouth Sore Mild Mint?

The generic name for Peroxyl Mouth Sore Mild Mint is Hydrogen Peroxide. There are 12 other brand versions of Hydrogen Peroxide.

What is the NDC code for Peroxyl Mouth Sore Mild Mint 15 mg/mL?

The NDC (National Drug Code) for Peroxyl Mouth Sore Mild Mint 15 mg/mL is 0126-0083, listed by Colgate Oral Pharmaceuticals Inc..